27ga Curved Laser Probe - Alcon Compatible VS0120.27A

GUDID B384VS012027A5

27ga Curved Laser Probe - Alcon Compatible

VORTEX SURGICAL, LLC

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• Primary Device ID: B384VS012027A5
• NIH Device Record Key: 2c4de015-1d3a-45b9-9dfa-339a8e2ad2f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 27ga Curved Laser Probe - Alcon Compatible
• Version Model Number: VS0120.27A
• Catalog Number: VS0120.27A
• Company DUNS: 080375891
• Company Name: VORTEX SURGICAL, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Dimensions

• Needle Gauge: 27 Gauge
• Needle Gauge: 27 Gauge
• Needle Gauge: 27 Gauge
• Needle Gauge: 27 Gauge
• Needle Gauge: 27 Gauge
• Needle Gauge: 27 Gauge
• Needle Gauge: 27 Gauge
• Needle Gauge: 27 Gauge
• Needle Gauge: 27 Gauge
• Needle Gauge: 27 Gauge
• Needle Gauge: 27 Gauge
• Needle Gauge: 27 Gauge
• Needle Gauge: 27 Gauge
• Needle Gauge: 27 Gauge
• Needle Gauge: 27 Gauge
• Needle Gauge: 27 Gauge
• Needle Gauge: 27 Gauge

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B384VS012027A1 [Primary]
HIBCC	B384VS012027A5 [Package]; Contains: B384VS012027A1; Package: box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021696

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

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